title: Deep sedation during gastrointestinal endoscopy: propofol-fentanyl and midazolam-fentanyl regimens.
abstract: OBJECTIVE
  To compare deep sedation with propofol-fentanyl and midazolam-fentanyl regimens during upper gastrointestinal endoscopy.
  
  
  METHODS
  After obtaining approval of the research ethics committee and informed consent, 200 patients were evaluated and referred for upper gastrointestinal endoscopy. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation using the observer's assessment of alertness/sedation (OAA/S) score and bispectral index (BIS). We evaluated patient and physician satisfaction, as well as the recovery time and complication rates. The statistical analysis was performed using SPSS statistical software and included the Mann-Whitney test, χ² test, measurement of analysis of variance, and the κ statistic.
  
  
  RESULTS
  The times to induction of sedation, recovery, and discharge were shorter in the propofol-fentanyl group than the midazolam-fentanyl group. According to the OAA/S score, deep sedation events occurred in 25% of the propofol-fentanyl group and 11% of the midazolam-fentanyl group (P = 0.014). Additionally, deep sedation events occurred in 19% of the propofol-fentanyl group and 7% of the midazolam-fentanyl group according to the BIS scale (P = 0.039). There was good concordance between the OAA/S score and BIS for both groups (κ = 0.71 and κ = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group and 26% of the midazolam-fentanyl group (P = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (P < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination.
  
  
  CONCLUSIONS
  Deep sedation occurred with propofol-fentanyl and midazolam-fentanyl, but was more frequent in the former. Recovery was faster in the propofol-fentanyl group.
authors.affiliation: Department of Gastroenterology, Hospital das Clínicas, University of Sao Paulo Medical School, Sao Paulo, CEP 05403-900, Brazil. marcoslera@gmail.com
authors.forename: Marcos Eduardo
authors.initials: ME
authors.lastname: Lera dos Santos
authors.forename: Fauze
authors.initials: F
authors.lastname: Maluf-Filho
authors.forename: Dalton Marques
authors.initials: DM
authors.lastname: Chaves
authors.forename: Sergio Eiji
authors.initials: SE
authors.lastname: Matuguma
authors.forename: Edson
authors.initials: E
authors.lastname: Ide
authors.forename: Gustavo de Oliveira
authors.initials: Gde O
authors.lastname: Luz
authors.forename: Thiago Ferreira
authors.initials: TF
authors.lastname: de Souza
authors.forename: Fernanda C Simões
authors.initials: FC
authors.lastname: Pessorrusso
authors.forename: Eduardo Guimarães Hourneaux
authors.initials: EG
authors.lastname: de Moura
authors.forename: Paulo
authors.initials: P
authors.lastname: Sakai
mesh_terms: D000328:Adult; D000368:Aged; D000762:Anesthesia Recovery Period; D019162:Anesthetics, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D018686:Anesthetics, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D001938:Brazil; D016009:Chi-Square Distribution; D003243:Consciousness / Q000187:drug effects; D054810:Deep Sedation / Q000009:adverse effects / Q000379:methods*; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008874:Midazolam / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010351:Patient Discharge; D017060:Patient Satisfaction; D015742:Propofol / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors
chemical_list: D019162:Anesthetics, Combined; D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives; D008874:Midazolam; D005283:Fentanyl; D015742:Propofol
keywords: Adverse effects; Anesthetic administration; Anesthetic dose; Deep sedation; Endoscopy